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Neuromodulation of Spinal Circuits: Effects on Spasticity, Nociception, and Motor Activation (Phase II)

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What is being tested

Transcutaneous Spinal Stimulation

Other
Who is being recruted

Central Nervous System Diseases+3

+ Nervous System Diseases

+ Spinal Cord Diseases

Over 16 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2024
See protocol details

Summary

Principal SponsorShepherd Center, Atlanta GA
Study ContactJaclyn Miller, PT, DPTMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 19, 2024

Actual date on which the first participant was enrolled.

This study is exploring a treatment method called transcutaneous spinal stimulation (TSS) to help people with spasticity, which is a condition where muscles are continuously contracted, causing stiffness or tightness. TSS is a noninvasive approach that involves applying electrical stimulation on the skin over the lower back and stomach. This method has been found to reduce muscle tightness without the side effects that often accompany drug therapies. However, the ideal frequency of electrical pulses for the most effective results is still unknown. This study aims to find out which frequency works best by comparing three different ones, with the hope of improving treatment for those with spasticity and possibly reducing related pain and improving muscle strength. Participants in the study will undergo a session where their levels of muscle stiffness, strength, and pain are measured before and after receiving 30 minutes of TSS. The stimulation involves electrical pulses delivered through the skin, which is painless and does not require any surgical procedures. Researchers will evaluate the effects of different frequencies of electrical pulses on the nerves to determine their impact on reducing spasticity, alleviating pain, and enhancing muscle function. This study is important because it could lead to a more effective, non-drug treatment option for people dealing with these symptoms.

Official TitleNeuromodulation of Spinal Circuits: Effects on Spasticity, Nociception, and Motor Activation (Phase II)
NCT06214208
Principal SponsorShepherd Center, Atlanta GA
Study ContactJaclyn Miller, PT, DPTMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

36 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 16 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Central Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesSpinal Cord InjuriesWounds and InjuriesTrauma, Nervous System

Criteria

7 inclusion criteria required to participate
Participants must agree to allow use of health information.

Participants should be 16 years old or older.

Participants must have had a spinal cord injury (SCI) of any severity (AIS A, B, C, or D) that happened at least 3 months ago.

Objectively measurable spasticity in your legs.

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13 exclusion criteria prevent from participating
People with spinal issues that are getting worse, such as degenerative or progressive vascular disorders.

People neurological problems other than SCI.

People with an injury level is below T12.

People with un-treated or uncontrolled heart problems that the lead investigator believes could be affected by stimulation or affected by an increase in blood pressure.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Intervention will be applied with a 30 Hz frequency.

Group II

Experimental
Intervention will be applied with a 50 Hz frequency.

Group III

Experimental
Intervention will be applied with an 80 Hz frequency.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Shepherd Center, Inc.

Atlanta, United StatesOpen Shepherd Center, Inc. in Google Maps
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One Study Center